Complementary and Alternative Therapies and Conventional Medical Therapies Should Be Held to Same Standards; Revised Regulation of Dietary Supplements Is Needed to Ensure Product Quality and Safety

WASHINGTON -- Stating that health care should strive to be both comprehensive and evidence-based, a new report from the Institute of Medicine of the National Academies calls for conventional medical treatments and complementary and alternative treatments to be held to the same standards for demonstrating clinical effectiveness. The same general research principles should be followed in evaluating both types of treatments, although innovative methods to test some therapies may have to be devised, said the committee that wrote the report.

The committee noted in particular the escalating popularity of dietary supplements as well as the lack of consistency and quality in these products, which are an important component of several complementary and alternative approaches. Product inconsistency hinders health professionals' abilities to guide patients on the use of supplements and researchers' ability to study them. The report calls on Congress to work with stakeholders to amend the regulation of supplements to improve quality control and consumer protections and to create incentives for research on the efficacy of these products.

"Ideally, health care should be comprehensive, grounded in the best available scientific evidence, and centered on patients' needs and preferences," said committee chair Stuart Bondurant, interim executive vice president for health sciences and executive dean, Georgetown University Medical Center, Washington, D.C. "Health professionals and patients should have sufficient information about safety and efficacy to take advantage of all useful therapies, both conventional and complementary and alternative. To that end, we believe that the same research principles and standards for showing effectiveness should apply to both conventional and complementary and alternative treatments. And because evidence is a key element of prudent decision-making, we need to change the current regulation of dietary supplements in this country to encourage more studies of these widely used products and to ensure their quality," he said.

Written to assist the National Institutes of Health in developing research methods and setting priorities for evaluating products and approaches within complementary and alternative medicine (CAM), the report also assesses what is known about Americans' reliance on these therapies. Use of CAM is widespread among the U.S. public, with more than one-third of adults reporting that they have pursued some form of these treatments, which include products such as herbal remedies, techniques such as acupuncture, and schools of practice such as naturopathy. Fewer than 40 percent of CAM users have disclosed their use of such therapies to their physicians. More than half of physicians report that they would encourage patients to talk to them about using CAM and would refer them for treatments that fall into that category. However, much is still unknown about how and why people use these therapies in conjunction with or in lieu of conventional therapies.

A common set of methods and standards for generating and interpreting evidence is necessary if health care providers are to make informed decisions about the use of both conventional treatments and CAM. It has been argued that characteristics of CAM therapies -- such as customization of treatments, variations in how practitioners perform treatments, or the holistic nature of many of these practices -- make it difficult to apply traditional clinical studies to them. Randomized controlled trials (RCTs) are the gold standard for providing evidence of efficacy, the committee said, but other study designs can generate useful information on treatments that do not lend themselves to RCTs. Observational studies, case control studies, and studies that specifically measure patients' expectations, emotional states, and other self-healing processes can provide useful data. Some conventional treatments, such as psychotherapy, also have similar characteristics that make them incompatible with RCTs, but they have been successfully evaluated via other methods, the committee noted.

Because many CAM products and approaches have not undergone formal testing and because resources to conduct research are finite, the report outlined several criteria to help determine which CAM therapies to prioritize for study. These same criteria apply equally well to as-yet untested conventional treatments, the committee noted. They include the prevalence and severity of the target health condition; existing evidence that the therapy is effective or may have safety issues; whether there is a plausible biological mechanism by which the therapy might work or the likelihood that research will discover a mechanism; and the likelihood that research will yield unambiguous results. Inability to meet any one of the criteria should not necessarily exclude a therapy from consideration, the report says.

To foster more research on the effectiveness and safety of CAM -- as well as on how these therapies compare with one another or with conventional treatments -- practitioners need to be trained in research principles and methods. Studies depend on the involvement of those who understand the therapies' characteristics and goals, but CAM training programs focus on preparing students for practice, and few practitioners learn how to conduct research. At the same time, because CAM use is becoming so widespread, all doctors, nurses, and other health care providers should receive education about these treatments during their professional education, the committee urged.

Dietary supplements, such as herbal products and vitamin pills, are among the most widely and increasingly used forms of CAM; use of herbal products jumped 380 percent between 1990 and 1997, for example. The Dietary Supplement Health and Education Act (DSHEA) mandates that supplements be regulated as foods rather than drugs, which means that supplement manufacturers are not required to conduct safety or efficacy tests on their products. Given that manufacturers are not required to conduct testing and are unable to patent many supplements, there is little incentive for supplement makers to invest in research on the effectiveness of these products. Moreover, the general lack of quality control for dietary supplements is problematic because researchers need consistent samples to conduct studies that could further elucidate these products' effectiveness and potential uses, the report says.

The committee also noted that although there are some restrictions on what information and claims can be included on labels, officials at the Federal Trade Commission have described a proliferation of unfounded and exaggerated claims for supplements. This is of concern because many consumers use these products without consulting a health care professional.

To remedy this situation, the report calls on Congress and the appropriate federal agencies to work with industry representatives, researchers, consumers, and other stakeholders to amend DSHEA to implement quality-control standards for each step of the manufacturing process and to enforce more accurate labeling and disclosures and other consumer protections. In addition, the broader regulatory scheme for supplements should be revised to create incentives for privately funded research on the effectiveness of products and brands and on how consumers use these products.

The study was sponsored by the National Institutes of Health and Agency for Health Care Research and Quality. The Institute of Medicine is a private, nonprofit institution that provides health policy advice under a congressional charter granted to the National Academy of Sciences. A committee roster follows.Pre-publication copies of Complementary and Alternative Medicine in the United Statesare available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

INSTITUTE OF MEDICINEBoard on Health Promotion and Disease Prevention

Committee on the Use of Complementary and Alternative Medicine by the American Public